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CDK4/6 Inhibitor

Palbociclib for Advanced Solid Cancers and Non-Hodgkin Lymphoma

Phase 2

Waitlist Available

Led By Rajen Mody

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For patients with solid tumors without known bone marrow involvement

In addition to the actionable mutations, positive Rb expression by immunohistochemistry is required for study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 5 years

Awards & highlights

Study Summary

This trial studies how well palbociclib works in treating pediatric patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders.

Who is the study for?

This trial is for children and young adults aged up to 21 with Rb positive advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have returned or are treatment-resistant. Participants must have measurable disease, adequate organ function, no prior CDK4/6 inhibitors like palbociclib use, and be able to swallow capsules. Pregnant individuals or those on certain medications are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of palbociclib in treating patients with specific cancer types that have genetic alterations affecting cell growth. It aims to see if this drug can stop cancer cells by inhibiting proteins necessary for their proliferation.See study design

What are the potential side effects?

Palbociclib may cause low blood cell counts leading to increased infection risk, bleeding issues, fatigue; nausea; hair thinning; rash; diarrhea; mouth sores; loss of appetite and potential liver problems as indicated by changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My solid tumor cancer has not spread to my bone marrow.

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My cancer cells show positive Rb expression.

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I am enrolled in APEC1621SC and assigned to APEC1621I due to a specific mutation.

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I can swallow pills without any issues.

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I have received a stem cell infusion, with or without full-body radiation.

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I have never taken drugs like palbociclib or any CDK4/6 inhibitors.

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My kidney function is within the normal range for my age and gender.

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My bilirubin levels are within the normal range for my age.

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My body surface area is at least 0.87 square meters.

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I have received radiation therapy.

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I am between 12 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate

Secondary outcome measures

Percentage of Patients Experiencing Grade 3 or Higher Adverse Events

Progression Free Survival (PFS)

Other outcome measures

Changes in Tumor Genomics Over Time Through Evaluation of Circulating Tumor Deoxyribonucleic Acid

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (palbociclib)Experimental Treatment3 Interventions

Patients receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

2017

Completed Phase 3

~3760

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,348 Total Patients Enrolled

89 Trials studying Medulloblastoma

10,318 Patients Enrolled for Medulloblastoma

Rajen ModyPrincipal InvestigatorChildren's Oncology Group

1 Previous Clinical Trials

73 Total Patients Enrolled

Media Library

Medulloblastoma Research Study Groups: Treatment (palbociclib)

Medulloblastoma Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT03526250 — Phase 2

Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03526250 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions can be addressed through the use of Palbociclib?

"Palbociclib is known to be a viable option for the treatment of postmenopausal breast cancer."

Answered by AI

What criteria must a patient fulfill to be admitted into the research?

"To be admitted to this medical trial, individuals must possess germ cell cancer and be between 12 months old and 21 years of age. The team is looking for a total of 49 participants."

Answered by AI

Are there any open spots available for this research project?

"As of July 26th 2022, recruitment for this trial has ceased. It was initially posted on June 25th 2018. For those looking to take part in a medical study, there are currently 5647 trials specifically for germ cell cancer and 133 studies including Palbociclib that require participants."

Answered by AI

Has Palbociclib been given authorization by the FDA?

"After assessing the available evidence, we at Power assign Palbociclib a 2 in terms of safety since it is still undergoing Phase 2 testing and has not yet been conclusively proven to be effective."

Answered by AI

How many individuals have expressed interest in participating in this trial?

"This research endeavour is no longer accepting applications, with the initial postdate being June 25th 2018 and last revision on July 26th 2022. Those looking for similar studies involving germ cell cancer can look at 5647 active clinical trials and 133 of those utilizing Palbociclib specifically."

Answered by AI

How many health care facilities are currently conducting this research within the state?

"Patients are being enrolled in this trial at various sites, such as the Roswell Park Cancer Institute in Buffalo, New york; State University of New York Upstate Medical University in Syracuse, Ohio; and Rainbow Babies and Childrens Hospital in Cleveland, Mississippi. These represent 3 out of a total 100 potential enrolment locations."

Answered by AI

Does this research encompass individuals younger than 65 years old?

"This particular trial is for participants aged between 12 months and 21 years old. Evidently, the number of clinical trials available to those below 18 and above 65 are 1085 and 5104 respectively."

Answered by AI

Has Palbociclib been subject to prior investigations?

"Palbociclib was initially investigated in 2012 at Unimed Medical Institute. There are 668 concluded studies and 133 active experiments, with many trials occurring out of Buffalo, New york."

Answered by AI